AIM-listed clinical stage biotech company
David Evans
Dr Richard Goodfellow
Professor Lindy Durrant
13th March 2012
1
Disclaimer
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David Evans
Non- Executive
Chairman
3
Dr Richard Goodfellow
Co-Chief Executive
4
Company Overview
Clinical stage immunotherapy company with novel ‘ImmunoBody’
DNA vaccine platform for cancer and chronic infectious diseases
Lead product (SCIB1 for melanoma) entered Phase I clinical trials in June 2010
with steady progress made in 2011
-Dose increased from 0.4mg to 4mg with no serious adverse effects
Follow up vaccine targeting NY-ESO-1 (SCIB2) at pre-clinical proof of principle
stage (lung, oesophageal, prostate, liver, gastric, ovarian, bladder cancers) with
more in the pipeline
Partnerships with Ichor Medical Systems, immatics Biotechnologies GmBH
and others to optimise immune response and generate new products
Antibody portfolio sale to Arana Therapeutics (now Cephalon/Teva) in 2006
Milestone payment of £2.85m received in November 2011 when SC104 started
Phase 1 clinical trials in USA
5
Industry Trends
Continued trend for Big Pharma to move away from in-house R&D and to
rely more on partnerships with Industry and Academia
Larger Biotechs becoming more aggressive buyers of innovative
companies and providing growing competition for Big Pharma
Pick up in M&A deal value in 2011 (e.g. Amgen/Biovex $1 billion)
Public markets still generally unsupportive of early stage Biotech (until
key value inflexion point reached)
Outstanding projects with future strategic value to third party will
succeed
6
Cancer Vaccine Sales Increasing
7
A Year of Steady Progress
Patient recruitment for Phase 1 trial of SCIB1 in melanoma completed
Dose escalation to highest dose of 4mg achieved with no serious adverse
effects
Follow up vaccine for lung and other cancers (SCIB2) produces outstanding
results in animal studies
Additional £1.73m (gross) raised in June 2011
Milestone payment of £2.85m received when SC104 entered clinical trials in
November 2011 confirming commercial value of Scancell science
Significant additional progress on technology platform
Fully funded to completion of Phase 2 clinical trial
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Listing on AIM
Share Information
October 2011
Placing
£1.58m raised
Share Price
Milestone payment of
£2.85m from
Cephalon Inc received
(10 for 1 Subdivision of Shares
occurred 25 July 2011)
Market Capitalisation at 1st January
2008- 2012
£1.6m raised
in PLUS float
April 2010 Placing
£2.5m raised
This data has been collated from information supplied by the London Stock Exchange, the PLUS
Market and analyst research notes from the last four years
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Strategy on Track
Validation of ImmunoBody platform through
- Clinical data on SCIB1
- Phase 1 data 2012
- Phase 2 data 2013
-
Pre-Clinical data on new ImmunoBody vaccines
-
New supporting technologies
Trade sale to large pharmaceutical or biotech company
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Professor Lindy Durrant
Co- Chief Executive
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SCIBI (melanoma)
High avidity CD8 and CD4 response
Better than synthetic peptide or whole antigen
Better than DNA antigen immunisation
NH2
NH2
Similar to DC vaccines
Works with gene gun, id/im electroporation
Induces anti-tumour activity in vivo
COOH
GMP manufactured
KEY:
No Toxicity
gp100 DR4 epitope (L1 and H3)
gp100 DR7,Dr53,DQ6 epitope (L3 and H1)
CTA May 2010
COOH
Clinical Trial June 2010
TRP-2 epitope (H2)
Metheringham et al., 2009 mabs
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Ichor TRIGRID™ Delivery System
Uses electrical fields to increase DNA drug delivery efficiency
Electrode array consists of four electrodes in a diamond-shaped
grid around a central injection needle
Simple hand-held device developed for use in humans
Can deliver equivalent does in man to mouse
Im easier to deliver in humans than id
Electrodes
Figure
2.
Application Cartridge
Integrated
Applicator
Injection
Needle
Pulse
Stimulator
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Phase I-II trial in stage IV/III melanoma
Start: June 2010
Primary Objective:
To demonstrate safety and tolerability
Secondary Objective:
To demonstrate cellular immune response (high avidity T-cells) and tumour response
Phase One
•
•
•
9 patients
3 subjects per cohort; 0.4mg, 2.0 mg or 4.0 mg
Progression only if adequate safety demonstrated at previous dose
Phase Two
•
•
13 subjects
Subjects to receive maximum tolerated dose provided no clear evidence of
improved efficacy at lower doses
0
3wks
6wks
3 months
14
6 months
Phase I-II trial in stage III/IV melanoma
•
GTAC approval for the trial was given in May 2010 and the
first patient was immunised in June 2010
•
5 centres: Nottingham, Manchester, Newcastle, Leeds and Southampton
•
Phase I fully recruited – no toxicity
•
Phase II starting 2 Q 2012
•
Phase I completed by end 2012
•
Phase II completed in 2013 with report in early 2014
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SCIB2-NYESO-1
1200
conrol
100
IB
av.spots/million splenocytes
•
Expressed by lung (SCLC), melanoma, oesophageal, liver,
gastric, prostate, ovarian and bladder cancers
Improves survival
90
80
P=0.044
%survival
•
• Vaccine encodes 20 epitopes
covers 90-100% of population
• Better than peptide
• Better than Dc peptide (Dendreon)
70
60
50
40
30
20
10
0
5
days post tumour challenge
15
25
35
DNA
peptide
DC+peptide
1000
800
p=0.0041
600
p=0.0003
400
200
0
1E-10 0.001
1E-09
0.0001
-08
1E
0.01
-07
1E0.1
1E-06
1
1E-05
10
peptide conc (M)
In combination with homspera it completely inhibits tumour growth
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Candidate for SCIB3?
• Novel patentable target (Patents being prepared)
• Widely expressed ( lung , ovarian , renal, leukaemias, sarcomas, melanoma,
oesophageal, liver, gastric and prostate cancers)
• Novel CD4 self epitope stimulates killer CD4 T cells
• Potent anti-tumour response
conrol
SCIB1
SCIB3
100
90
%survival
80
70
60
50
40
30
20
10
0
5
15
25
days post tumour challenge
35
45
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Summary
• Phase I recruited
• Phase II due to start April 2012
• SCIB2 NYESO-1 good anti-tumour response
• SCIB3 new patent good anti-tumour response
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Appendix
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Board of Directors
David Evans (Non-Executive Chairman)
Guided Shield Diagnostics Ltd through IPO, and then through its merger with Axis Biochemical ASA to form AxisShield plc. Non-executive Chairman of Epistem Holdings plc, Omega Diagnostics Group plc and EKF Diagnostics
Holdings plc, all AIM-listed biotech companies.
Professor Lindy Durrant (Founder and Joint Chief Executive Officer)
Founder of Scancell and internationally recognised immunologist in the field of tumour therapy, has worked for
20+ years in translational research, developing products for clinical trials including monoclonal antibodies for
diagnostic imaging and therapy and cancer vaccines.
Dr Richard Goodfellow (Co-founder and Joint Chief Executive Officer)
Key member of the Scancell management team since 1999, negotiating the 2006 Arana deal. 25+ years
international experience in the pharmaceutical industry, both major pharma and smaller biotech companies: held
key senior product launch and business roles at AstraZeneca and Scotia Pharmaceuticals, founder of Paradigm
Therapeutics and former director of Enact Pharma plc.
Nigel Evans (Non-exec and Company Secretary)
40 years of commercial and strategic responsibilities at senior levels in Rolls-Royce plc in the UK and overseas.
Previously chairman, he now oversees Scancell’s corporate and financial activities. Active investor in public and
private companies.
Michael Rippon (Non-executive Director)
40+ years experience in the motor industry. Active investor in small private companies and one of Scancell’s major
private investors. Appointed to the Board in 2004 as the Shareholder Representative.
Dr Matthew Frohn (Non-executive Director)
Dr of Biochemistry, has worked on research collaborations with Astra Zeneca, and at a British biotech subsidiary
before joining Oxford Technology Management in 1999. Manages Oxford Technology VCTs.
Kate Cornish-Bowden (Non-executive Director)
A Chartered Financial Analyst, Kate was managing director and head of Morgan Stanley Investment Management’s
Global Core Equity Team between 2002 and 2004. More recently, Kate has acted as a consultant providing financial
research to private equity and financial training firms and was appointed a director of Investec Structured
Products Calculus VCT plc in February 2011.
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Key Facts & Major Shareholders
Ticker
SCLP
Stock Exchange
AIM
Shares in Issue
194m
Share Price
6.5p
HSBC Global Custody Nominee
13.00
Sector
Pharmaceuticals &
Biotechnology
New Edge Group SA
9.04
Hygea VCT Plc
7.63
Professor Lindy Durrant
5.39
J G Helfenstein
5.38
Oxford Technology VCT
4.29
Share Nominees Ltd
3.48
Dr Richard Goodfellow
3.42
T Walthie
3.20
% of Issued
Share
Capital
Year ended
30.04.11
Year ended
30.04.2010
£
£
-
-
Operating Loss
(1,733,749)
(1,802,066)
Loss Before Taxation
(1,724,136)
(1802,639)
4,635,742
6,047,877
Revenue
Net (Liabilities) / Assets
Net cash outflow from
operating activities
Net funds at 30 April
(1,842,219)
(1,504,392)
1,110,630
2,830,145
December 2011
*Oxford Technology Management Limited does not hold
these Ordinary Shares directly but is the manager for the
Oxford Technology VCT plc which holds 666,663 Ordinary
Shares and Oxford Technology 3 VCT plc which holds
275,925 Ordinary Shares
21
Glossary
Antibodies
Proteins found in blood or other bodily fluids of vertebrates, used by the immune system to identify and neutralize foreign
objects, such as tumours
Antigen
A molecule that is recognised by an antibody or T-cell receptor
Avidity
How strongly two cells interact
Dendritic cells
A type of white blood cell that initiates an immune response
Electroporosis
The process where cell membrane pores are opened through the application of electromagnetic fields. An electroporosis
delivery system uses the electrical fields to increase DNA drug delivery efficiency by up to 1,000 fold
Epitope
A peptide that is recognised by a T cell
ImmunoBody
an antibody genetically engineered to express T cell epitopes from a tumour antigen
Immunotherapy
The use of the immune system to reject cancer. The patient's immune system is stimulated to attack the malignant tumour
cells, either through immunization of the patient (eg. by administering a cancer vaccine), or through the administration of
therapeutic antibodies as drugs
In vivo
In the body
Melanoma
A cancer which usually starts in either a mole or in normal-looking skin. About half of all melanomas start in normal skin. If
the skin cells (melanocytes) receive too much ultraviolet light (through sunlight or tanning booths), the cells may begin to
grow abnormally and become. cancerous Melanoma is the most serious type of skin cancer
Peptide
A string of amino acids
Secondary or
metastatic
Cancer that has spread from its original site. Melanoma is highly metastic
T cell
Type of white blood cell that is composed of CTL and helper cells
Cytotoxic (CTL) Tcells
Type of white blood cell that recognises and kills tumour or virally infected cells
Helper T cell
Type of white blood cell that recognises and secretes molecules to alert the immune system to the presence of a tumour or
virally infected cell
Translational
medicine
It integrates research inputs from the basic sciences, social sciences and political sciences to optimise both patient care and
also preventive measures which may extend beyond the provision of healthcare services
Vector
A molecule that encodes an epitope and targets the immune response
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